Key papers ✓ 5~ 3

• ✓ Positive human RCTObstet Gynecol · 2019

  Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.

  Humans1,267 peopleRandomizedPlacebo-controlledDouble-blind24 weeks

  Two identical phase 3 randomized, double-blind, placebo-controlled multicenter trials (RECONNECT); bremelanotide 1.75 mg subcutaneously as needed

  Two phase 3 RCTs (RECONNECT; 1,267 premenopausal women with HSDD) of 1.75 mg as needed for 24 weeks: desire scores rose (integrated +0.35 vs placebo, P<.001) and distress about low desire fell (-0.33, P<.001); nausea, flushing and headache occurred in 10% or more.

  Key resultDesire increased vs placebo (integrated 0.35, P<.001) and distress fell (integrated -0.33, P<.001); nausea, flushing and headache occurred in 10% or more

  Study details

  Studied

  Premenopausal women with hypoactive sexual desire disorder (mean age 39)

  Compared with

  Placebo

  Main outcome

  Change in FSFI-desire domain score and FSDS-DAO item 13 (distress)

  Sample

  1,267 women randomized in two identical phase 3 trials (1,202 in the modified intent-to-treat efficacy population)

  Authors' conclusion

  Bremelanotide significantly improved sexual desire and related distress in premenopausal women with HSDD, with a favorable safety profile; most adverse events were mild or moderate.

  Limitations

  Mostly white women (85.6%) from US sites (96.6%); industry-sponsored.

  DOI 10.1097/AOG.0000000000003500PubMed 31599840Free full text
• ✓ Positive meta-analysisJ Minim Invasive Gynecol · 2026

  Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options.

  Humanssize not reported36 studies pooled

  Systematic review and meta-analysis

  Systematic review and meta-analysis of treatments for female desire/arousal/orgasm dysfunction: bremelanotide improved total FSFI and its desire and arousal subscales and reduced distress.

  Study details

  Studied

  Women with sexual desire, arousal or orgasm dysfunction without sexual pain conditions

  Main outcome

  FSFI total and desire/arousal/orgasm subscales, FSDS

  Sample

  36 studies (26 RCTs, 10 single-arm); bremelanotide meta-analysed alongside CBT and flibanserin

  Authors' conclusion

  Bremelanotide improved total FSFI and desire and arousal subscales; CBT improved all domains and flibanserin improved desire; all three reduced distress.

  Limitations

  No direct CBT vs drug comparisons; heterogeneous terminology and outcome measures limited other conclusions.

  DOI 10.1016/j.jmig.2025.06.004PubMed 40543759
• ✓ Positive systematic reviewAnn Pharmacother · 2020

  Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.

  Humanssize not reported

  Systematic literature review of phase 2 and 3 trials

  Review of phase 2 and 3 trials: significant improvement in desire and reduced distress, though clinical benefit 'may only be modest'; nausea 39.9%, flushing 20.4%, headache 11%.

  Key resultMost common adverse effects: nausea (39.9%), facial flushing (20.4%) and headache (11%)

  Study details

  Studied

  Women with hypoactive sexual desire disorder

  Main outcome

  Desire, distress and adverse effects

  Sample

  Review of 2 phase 3 and 2 phase 2 trial reports

  Authors' conclusion

  Bremelanotide significantly improves desire and reduces distress, but the clinical benefit may only be modest; its place in therapy is unknown.

  Limitations

  Based on a small number of trial reports.

  DOI 10.1177/1060028019899152PubMed 31893927
• ~ Mixed reviewJ Sex Res · 2024

  Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.

  Humanssize not reported

  Re-analysis of measurement validity and unpublished outcomes from the RECONNECT trials

  Reanalysis of RECONNECT outcomes: effect sizes on 8 previously unpublished efficacy outcomes ranged from nil to small, and benefits were limited to measures with weak validity evidence for HSDD.

  Study details

  Studied

  Women with HSDD in the RECONNECT phase III bremelanotide trials

  Main outcome

  Validity of efficacy measures and effect sizes of unpublished outcomes

  Authors' conclusion

  Bremelanotide's benefits are statistically modest and limited to outcomes with scant evidence of validity among women with HSDD; unpublished outcome effect sizes ranged from nil to small.

  Limitations

  Several modest-benefit outcomes were likely derived post hoc.

  DOI 10.1080/00224499.2023.2175192PubMed 36809187
• ~ Mixed human RCTJ Womens Health (Larchmt) · 2022

  Safety Profile of Bremelanotide Across the Clinical Development Program.

  Humans3,500 peopleRandomizedPlacebo-controlledUp to 18 months in phase 3

  Review of safety data from the clinical development program

  Integrated safety data (3,500 subjects, 43 studies): nausea 40.0% vs 1.3% placebo, flushing 20.3%, headache 11.3%, injection-site reactions 5.4%; small transient blood-pressure rises; focal hyperpigmentation rare at labeled dosing but in over a third after 16 consecutive daily doses.

  Key resultNausea 40.0% vs 1.3%, flushing 20.3% vs 1.3%, headache 11.3% vs 1.9% with bremelanotide vs placebo

  Study details

  Studied

  Subjects across phase 1 to 3 bremelanotide studies

  Compared with

  Placebo in double-blind phase 3 portion

  Main outcome

  Adverse events

  Sample

  Development program of 3500 subjects in 43 completed studies; 1247 in integrated double-blind phase 3 safety population

  Authors' conclusion

  Adverse events were mostly mild to moderate; caution is advised in patients at risk of cardiovascular disease and blood pressure should be well controlled.

  Limitations

  Sponsor-program safety review; small transient blood pressure increases observed.

  DOI 10.1089/jwh.2021.0191PubMed 35147466
• ✓ Positive human RCTJ Sex Med · 2019

  Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.

  Humanssize not reportedRandomized

  Post hoc and planned responder analyses of a phase 2b dose-finding trial

  Phase 2b dose-ranging study in premenopausal women with HSDD and/or arousal disorder: at 1.75 mg, responder rates beat placebo on all 7 endpoints (P <= .03).

  Key resultResponder rates at 1.75 mg achieved significance vs placebo for all 7 endpoints (P ≤ .03)

  Study details

  Studied

  Premenopausal women with HSDD and/or FSAD in a phase 2b dose-ranging study

  Main outcome

  Responder rates on 7 patient-reported endpoints

  Authors' conclusion

  Bremelanotide was safe and well tolerated and showed significant efficacy vs placebo; responder analyses offer a way to determine clinically important effects.

  Limitations

  Several analyses were post hoc.

  DOI 10.1016/j.jsxm.2019.05.012PubMed 31277966
• ~ Mixed human RCTJ Sex Med · 2006

  An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.

  HumansEighteen premenopausal women (crossover)RandomizedPlacebo-controlledDouble-blindSingle dose, assessed within 24 hours

  Randomized, double-blind crossover; single intranasal 20 mg dose

  18 premenopausal women with arousal disorder, single intranasal dose crossover: more reported moderate/high desire after bremelanotide (P=0.011), but measured vaginal vasocongestion did not change.

  Key resultMore women reported moderate or high sexual desire after bremelanotide vs placebo (P = 0.0114); vaginal vasocongestion did not change significantly

  Study details

  Studied

  Premenopausal women with female sexual arousal disorder

  Compared with

  Placebo

  Main outcome

  Vaginal pulse amplitude and subjective sexual response

  Authors' conclusion

  This preliminary evaluation suggests bremelanotide may positively affect desire and arousal and is a promising candidate for further at-home study.

  Limitations

  Preliminary, small crossover study with a single dose.

  DOI 10.1111/j.1743-6109.2006.00268.xPubMed 16839319
• ✓ Positive human RCTDiabetes Obes Metab · 2022

  Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.

  Humanssize not reportedRandomizedPlacebo-controlledDouble-blindStudy A days 1-15; Study B three 4-day periods

  Two phase 1 single-centre randomized, double-blind, placebo-controlled trials (parallel and crossover)

  Two phase 1 RCTs in obese premenopausal women: 16 days of bremelanotide three times daily cut intake by about 400 kcal/day and weight by 1.3 kg more than placebo.

  Key resultStudy A: body weight reduction vs placebo -1.3 (-1.9 to -0.8) kg (p < .0001); caloric intake down about 400 kcal/day (p < .01)

  Study details

  Studied

  Premenopausal women with BMI >30 kg/m2

  Compared with

  Placebo

  Main outcome

  Body weight and caloric intake

  Sample

  Two phase 1 trials: Study A 30 per bremelanotide group; Study B 27 subjects

  Authors' conclusion

  Agonist activity at the MC4R may aid in reducing caloric intake and weight loss in obese women.

  Limitations

  Short phase 1 trials; only 15 of 27 subjects completed all phases of Study B.

  DOI 10.1111/dom.14672PubMed 35170192Free full text

Reported side effects

• commonNausea [ref] [ref] [ref]
• commonFlushing [ref] [ref] [ref]
• commonHeadache [ref] [ref] [ref]
• uncommonInjection-site reactions [ref]
• reportedTransient blood-pressure increase [ref]
• rareFocal hyperpigmentation [ref]

10 registered human trials (1 active)

✓ positive · ✗ negative · ~ mixed · ? inconclusive, judged on each paper's own main outcome. Grades: A strong human evidence → D little or none. Papers and verdicts are drawn from PubMed, Europe PMC and Russian journals (CyberLeninka); not medical advice.